Organization name

Integra LifeSciences Corporation

SRN

US-MF-000007196

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• Failure to appropriately adjust the rate of CSF outflow through the external drainage system may result in potential serious injury to the patient. Patients undergoing external drainage and/or intracranial pressure monitoring must be kept under constant supervision of trained personnel familiar with the use of intracranial and lumbar pressure monitoring techniques. Improper vigilance or improper drainage system setup can lead to overdrainage or underdrainage and potentially serious injury to the patient.

  OTHER

• Patients with cerebrospinal fluid drainage systems must be kept under close observation for signs and symptoms of changing intracranial pressure. These signs and symptoms may vary from patient to patient. Increased intracranial pressure may be characterized by, but not limited to, headache, vomiting, irritability, listlessness, drowsiness, other signs of deterioration of consciousness, and nuchal rigidity. In an infant, increased scalp tension at the anterior fontenelle and congestion of scalp veins may be noted.

  OTHER

• Proper alignment of the drainage system is critical whenever the system is open to drainage. It is essential that neither the patient nor the drainage system be raised or lowered accidentally. Height changes should only be made by qualified personnel on the orders of the physician.

  OTHER

• This device is not designed, sold, or intended for use except as indicated.

  OTHER

Primary placement in Belgium; available across 18 countries total.

Trade name

Evolution™

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

10381780112242

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

038178B0020CSSZM

Reference / catalog number

INS410

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

EVOLUTION POLE MOUNT ASSEMBLY WITH CMH20 AND MMHG (extended scale)

Additional information URL

https://labeling.integralife.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.